Pfizer’s biosimilar of anemia treatments gets FDA nod

Pfizer’s biosimilar of anemia treatments gets FDA nod

Pfizer Inc’s biosimilar of anemia treatments from Amgen Inc and Johnson & Johnson was approved by U.S. health regulators on Tuesday setting it up to compete against the established brands

A company logo is seen at a Pfizer office in Dublin, Ireland November 24, 2015. Pfizer Inc said on November 23 it would buy Botox maker Allergan Plc in a deal worth $160 billion to slash its U.S. tax bill, rekindling a fierce political debate over the financial maneuver. REUTERS/Cathal McNaughton

The approval comes one year after the U.S. Food and Drug Administration rejected the drug, Retacrit, a copy of Amgen’s Epogen and Johnson & Johnson’s Procrit, as a treatment for a drop in red blood cells caused by chronic kidney disease, chemotherapy, or the use of zidovudine in patients with HIV.

The biosimilar was also approved for use before and after surgery to safeguard against the need for red blood cell transfusions due to blood loss from surgery.

Amgen earned a revenue of $1.10 billion from Epogen in 2017, which accounted for about 5 percent of the company’s total sales.

Johnson & Johnson’s Procrit brought in sales of $972 million in 2017, accounting for 2.7 percent of its total sales.

Last year, an independent panel of advisors to the U.S. regulator recommended Retacrit’s approval, but the agency rejected the drug citing here issues with a potential manufacturing site in Kansas.